Lindgren H, Qvarfordt P, Åkesson M, Bergman S, Gottsäter A
Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden; Department of Surgery, Helsingborg Hospital, Helsingborg, Sweden.
Department of Surgery, Helsingborg Hospital, Helsingborg, Sweden.
Eur J Vasc Endovasc Surg. 2017 May;53(5):686-694. doi: 10.1016/j.ejvs.2017.01.026. Epub 2017 Mar 31.
Invasive treatment of intermittent claudication (IC) because of severe atherosclerotic stenosis or occlusion in the superficial femoral artery (SFA) is controversial. This prospective randomised trial was performed to assess the impact on health related quality of life (HRQoL) of primary stenting with nitinol self expanding stents compared with best medical treatment alone in patients suffering from stable IC due to SFA disease.
One hundred patients with stable IC caused by SFA disease from seven Swedish hospitals treated with best medical treatment (BMT) were randomised to either the stent (n = 48) or the control (n = 52) group. Change in HRQoL assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 12 months after treatment was the primary outcome measure. Improvement in the Walking Impairment Questionnaire (WIQ), ankle brachial index (ABI), and walking distance were secondary outcomes.
HRQoL improved significantly. In the stent group the following SF-36 domains improved: Physical Function, 19 points (p < .001); Bodily Pain, 14 points (p = .001); General Health, 6 points (p = .019); Vitality, 10 points (p = .004); Physical Component Summary, 6.5 points (p < .001); EQ5D, 0.14 points (p = .008); and WIQ 22 points (p < .001). They were unchanged in the control group. Both ABI (from 0.58 ± 0.11 to 0.86 ± 0.19, p < .001, in the stent group and from 0.63 ± 0.17 to 0.70 ± 0.20, p = .005, in the control group) and walking distance (WD) (from 171 ± 90 meters to 613 ± 381 meters, p < .001, in the stent group and from 209 ± 106 m to 335 ± 321 meters, p = .012, in the control group) improved, and at 12 months both the ABI (p < .001) and the WD (p = .001) were higher in the stent group.
In patients with IC caused by lesions in the SFA, the addition of primary stenting to BMT was associated with significant improvement in HRQoL, ABI, and walking distance after 12 months follow-up compared with BMT alone.
对于因股浅动脉（SFA）严重动脉粥样硬化狭窄或闭塞导致的间歇性跛行（IC）进行侵入性治疗存在争议。本前瞻性随机试验旨在评估，对于因SFA疾病导致稳定型IC的患者，与单纯最佳药物治疗相比，使用镍钛诺自膨胀支架进行初次支架置入术对健康相关生活质量（HRQoL）的影响。
来自瑞典七家医院的100例因SFA疾病导致稳定型IC且接受最佳药物治疗（BMT）的患者，被随机分为支架组（n = 48）或对照组（n = 52）。治疗12个月后，通过简短健康调查问卷（SF - 36）和欧洲五维健康量表（EQ5D）评估HRQoL的变化是主要结局指标。步行障碍问卷（WIQ）、踝臂指数（ABI）和步行距离的改善是次要结局指标。
HRQoL显著改善。在支架组中，以下SF - 36领域有所改善：身体功能，提高19分（p <.001）；身体疼痛，提高14分（p =.001）；总体健康，提高6分（p =.019）；活力，提高10分（p =.004）；身体成分总结，提高6.5分（p <.001）；EQ5D，提高0.14分（p =.008）；WIQ提高22分（p <.001）。对照组则无变化。ABI（支架组从0.58±0.11提高到0.86±0.19，p <.001，对照组从0.63±0.17提高到0.70±0.20，p =.005）和步行距离（WD）（支架组从171±90米提高到613±381米，p <.001，对照组从209±106米提高到335±321米，p =.012）均有所改善，且在1个月时，支架组的ABI（p <.001）和WD（p =.001）均更高。
对于因SFA病变导致IC的患者，与单纯BMT相比，在BMT基础上加用初次支架置入术在12个月随访后，HRQoL、ABI和步行距离均有显著改善。
